Drug

Brivaracetam

As of the edition of 20 October 2026, Brivaracetam is a small molecule: marketed, first approved in 2016 (EU); acts on SV2A; US protection ended in 2026.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2026
Kind
Small molecule
Brand name
Briviact
First approved
13 January 2016 (EU)
Approvals on record
11 in 4 regions
Holder of the most recent approval
SUN FARMACÊUTICA DO BRASIL LTDA; 5 holders in all
Registered trials
52, 5 stopped early
Disease areas
Nervous system; Inherited and neonatal; Injuries; Cancer; Mental health

US protection

US protection ended in 2026.

The last listed US drug-substance patent ended in 2026. The application that gives this date is held by UCB.

This is the US only, and it is not the date generics or biosimilars can enter.

The exact date and the listings behind it

In the product

8 listings count towards this date. The exact date and each listing are in the product.

See the exact date and the 8 listings behind itRequest access. Nothing is shown until you do.

Companies that need a new molecule because of this drug

1 company on route B because of this drug.

Companies on route B for this drug

In the product

1 company is on route B because of Brivaracetam.

Target

GeneProteinUniProt
SV2ASynaptic vesicle glycoprotein 2AQ7L0J3

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated5400
Phase 111801
Phase 210811
Phase 3262123
All trials52

Who has held its approvals

CompanyRoleYears
UCBApplicant, Acquired holder and Lead sponsor of trials2002 to now
AdiumApplicant2026 to now